Evidence map›Paper›PMID 36357430›Full record

ArticleScientific data2022

Rethinking clinical study data: why we should respect analysis results as data.

Joana M Barros, Lukas A Widmer, Mark Baillie, Simon Wandel

Abstract read
In one paragraph

Article in Scientific data, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Joana M Barros *Analytics, Novartis Pharma AG, Basel, Switzerland. joanamarquesbarros@gmail.com.ORCID 0000-0002-2952-5420
Lukas A WidmerAnalytics, Novartis Pharma AG, Basel, Switzerland.ORCID 0000-0003-1471-3493
Mark BaillieAnalytics, Novartis Pharma AG, Basel, Switzerland. mark.baillie@novartis.com.ORCID 0000-0002-5618-0667
Simon WandelAnalytics, Novartis Pharma AG, Basel, Switzerland.ORCID 0000-0002-1442-597X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development and approval of new treatments generates large volumes of results, such as summaries of efficacy and safety. However, it is commonly overlooked that analyzing clinical study data also produces data in the form of results. For example, descriptive statistics and model predictions are data. Although integrating and putting findings into context is a cornerstone of scientific work, analysis results are often neglected as a data source. Results end up stored as "data products" such as PDF documents that are not machine readable or amenable to future analyses. We propose a solution to "calculate once, use many times" by combining analysis results standards with a common data model. This analysis results data model re-frames the target of analyses from static representations of the results (e.g., tables and figures) to a data model with applications in various contexts, including knowledge discovery. Further, we provide a working proof of concept detailing how to approach standardization and construct a schema to store and query analysis results.

Indexed as

Information Storage and RetrievalClinical Studies as Topic

Identifiers

PMID36357430
PMCPMC9649650

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.